1.Effect of Transcutaneous Electrical Acupoint Stimulation on Stress Response in Patients Undergoing Unilateral Biportal Endoscopy
Yanan LI ; Zhengzuo WAN ; Xueliang DONG ; Shiyi TANG ; Xuelai YU
Journal of Traditional Chinese Medicine 2026;67(10):1071-1077
ObjectiveTo explore the effect of transcutaneous electrical acupoint stimulation (TEAS) on stress response in patients undergoing unilateral biportal endoscopy (UBE) and to identify optimal TEAS parameters. MethodsA total of 96 patients undergoing UBE were randomly grouped into total intravenous anesthesia (TIVA) group, acupuncture-assisted anesthesia with continuous waves (AACW) group, and acupuncture-assisted anesthesia with sparse-dense waves (AASDW) group, with 32 patients per group. All groups were given a standardized TIVA protocol. In the AACW group (100 Hz continuous wave stimulation) and the AASDW group (2/100 Hz sparse-dense wave stimulation), TEAS intervention was applied to both bilateral Zusanli (ST36) and Sanyinjiao (SP6) 30 minutes before TIVA induction and continued until the end of the surgery. In the TIVA group, electrodes were only connected without electrical stimulation. The stress response indicators including cortisol (Cor) and adrenocorticotropic hormone (ACTH), heart rate (HR), mean arterial pressure (MAP), and bispectral index (BIS) at before anesthesia induction (T0), after tracheal intubation (T1), during laminectomy (T2), and 1 hour after surgery (T3) were compared across groups. The operation duration, anesthesia duration, extubation and recovery duration were recorded, as well as pain intensity including visual analogue scale (VAS), and sedation level (by Ramsay sedation score) at 2, 6, 12 hours after surgery, and postoperative complications. ResultsThe AACW group and AASDW group had lower ACTH and COR levels at T1, T2 and T3, as well as lower HR and MAP levels at T1 and T2 than TIVA group, with AASDW group being lower than AACW group (P<0.05). At T3, the AASDW group had higher BIS than TIVA group and AACW group (P<0.05). No significant difference in operation duration was observed (P>0.05). The AACW group and AASDW group had shorter anesthesia, extubation and recovery duration than TIVA group, with AASDW group being the shortest (P<0.05). The VAS scores at 2 h, 6 h, and 12 h after surgery in the AACW and AASDW groups were lower than those in the TIVA group, with the AASDW group showing significantly lower scores than the AACW group (P<0.05). The Ramsay sedation scores in the AASDW group were lower than those in the AACW group at 2 h and 6 h after surgery (P<0.05). The total incidence of complications in the AASDW group was 6.25% (2/32), significantly lower than 28.13% (9/32) in the TIVA group (P<0.05). ConclusionTEAS can effectively suppresses stress response in patients undergoing UBE, with the 2/100 Hz sparse-dense wave parameter being most effective, which can stabilize hemodynamics, accelerate recovery, improve postoperative sedation and analgesia quality, and reduces complications.
2.Qiangjing Tablets Alleviate Oxidative Stress Damage in Varicocele by Regulating Keap1/Nrf2 Signaling Pathway
Liang DONG ; Fang YANG ; Jingyi ZHANG ; Xinyi TANG ; Yulin LI ; Xujun YU ; Degui CHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(14):347-359
ObjectiveTo explore the mechanism by which Qiangjing tablets (QJT) alleviate the spermatogenic function damage caused by varicocele (VC) based on the Kelch-like ECH-associated protein 1 (Keap1)/nuclear factor erythroid 2-related factor 2 (Nrf2) signaling pathway-mediated oxidative stress. MethodsTen Sprague-Dawley (SD) rats were randomly assigned into a control group and a model group. Pathological examination confirmed the stability of the model. Thirty-six SD rats were randomized into control, model, low-dose (0.23 g·kg-1) QJT, medium-dose (0.46 g·kg-1) QJT, high-dose (0.92 g·kg-1) QJT, and mazhilin (61.7 mg·kg-1) groups, with 6 rats in each group. A rat model of experimental left varicocele (ELV) was established by partially ligating the left renal vein to simulate the human nutcracker syndrome. The rats were administrated with corresponding agents once a day for 28 consecutive days. The in vitro testicular culture model of rats was established through the Transwell chamber method and intervened with QJT-containing sera (2.3, 4.6, and 9.2 g·kg-1). Microscopic observation was carried out for the morphology of the left kidney. A micrometer was used to measure the diameter of the left spermatic vein (LSV). The body weights of rats were recorded weekly, and the epididymis and testis weights were measured. The pathological changes of the testicular tissue was observed via hematoxylin-eosin (HE) staining. The levels of testosterone (T) in the cell culture supernatant and reactive oxygen species (ROS) in the rat testicular tissue were measured by enzyme-linked immunosorbent assay (ELISA). Flow cytometry was employed to determine the ROS content. Immunohistochemical staining was conducted to analyze Keap1, Nrf2, 3β-hydroxysteroid dehydrogenase (3β-Hsd), GATA-binding protein-4 (Gata-4), and proto-oncogene receptor tyrosine kinase (C-kit). The ultrastructure of the tissue was observed by transmission electron microscopy (TEM). Cell apoptosis was detected by terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL) staining. The expression of Keap1, Nrf2, glutathione S-transferase α2 (Gsta2), glutathione S-transferase μ1 (Gstm1), heme oxygenase-1 (HO-1), quinone oxidoreductase 1 (Nqo1), and thioredoxin reductase 1 (Txnrd1) was quantified by Real-time quantitative polymerase chain reaction(Real-time PCR) and Western blot. ResultsCompared with the control group, the ROS content and the percentage of apoptotic cells in the model group were significantly increased (P<0.01), the T concentration was significantly decreased (P<0.01), the mRNA and protein expressions of Keap1 were significantly increased (P<0.01), and the mRNA and protein expressions of Nrf2, Gsta2, Gstm1, HO-1, Nqo1 and Txnrd1 were significantly decreased (P<0.05). Compared with the model group, the ROS content and the percentage of apoptotic cells in each dose group of the Qiangjing Tablets were significantly reduced (P<0.05), and the mRNA and protein expressions of Keap1 were significantly decreased (P<0.05), while the mRNA and protein expressions of Nrf2, Gsta2, Gstm1, HO-1, Nqo1 and Txnrd1 were significantly increased (P<0.05). ConclusionQJT improves sperm motility in the rat model of VC by modulating the Keap1/Nrf2 signaling pathway and reducing oxidative stress injury.
3.Effects of Gandou Fumu Decoction on hepatic fibrosis,iron metabolism,and ferroptosis in patients with hepatolenticular degeneration
Chenling ZHAO ; Guofang YU ; Liwei TIAN ; Mengying ZHANG ; Lulu TANG ; Wenming YANG ; Ting DONG
Journal of Beijing University of Traditional Chinese Medicine 2025;48(5):625-635
Objective To investigate the effects of Gandou Fumu Decoction on liver fibrosis,iron metabolism,and ferroptosis in patients with hepatolenticular degeneration(Wilson disease,WD).Methods Seventy-eight hospitalized patients with WD characterized by kidney and liver deficiency,with phlegm and blood stasis,from the Department of Neurology,the First Affiliated Hospital of Anhui University of Chinese Medicine,were randomly assigned to two groups using a random number table method.The control group(n=39)received sodium dimercaptosulfonate in combination with a low-copper and high-protein diet.The observation group(n=39)received the same treatment as the control group,with the addition of Gandou Fumu Decoction(one dose per day,taken twice daily,in the morning and evening).Both groups underwent six treatment cycles,each lasting eight days.Ultrasonographic parameters,including portal vein main trunk diameter(PVMD),portal vein velocity(PVV),shear wave velocity(SWV),liver stiffness measurement(LSM),serum liver fibrosis markers(hyaluronic acid[HA],laminin[LN],procollagen typeⅢN-terminal peptide[PⅢNP],collagen type Ⅳ[CⅣ],aspartate aminotransferase to platelet ratio index[APRI],fibrosis-4 index[FIB-4]),and iron metabolism indicators(serum iron[SI],ferritin[FT])were compared before and after treatment.The relationship between baseline iron metabolism markers and ultrasonographic parameters,as well as serum liver fibrosis markers,was analyzed.Clinical efficacy,traditional Chinese medicine(TCM)syndrome scores,and adverse reactions were also compared between the groups.Additionally,bioinformatics analysis was performed to identify potential targets of Gandou Fumu Decoction for WD treatment.Peripheral blood mononuclear cells were collected from a normal group of 20 healthy individuals,as well as from both the control and observation groups before and after treatment.Real time fluorogenic quantitative PCR was performed to validate the expression changes of these targets across the groups.Results Compared with pre-treatment values,no significant changes were observed in PVMD levels in either group after treatment.No significant change in PVV was observed in the control group,whereas a significant decrease was noted in the observation group(P<0.01).SWV,LSM,HA,LN,PⅢNP,CⅣ,APRI,FIB-4,and FT levels were significantly reduced compared to pre-treatment levels(P<0.05,P<0.01),whereas SI remained unchanged.Compared with the control group,the observation group had no significant difference in PVMD but had significantly lower PVV,SWV,LSM,HA,LN,PⅢNP,CⅣ,APRI,FIB-4,and FT levels(P<0.05,P<0.01),whereas SI remained unchanged.The total effective rate of treatment in the observation group was significantly higher than that in the control group(P<0.05).Both groups showed a significant reduction in TCM syndrome scores after treatment(P<0.01),with a significantly greater reduction observed in the observation group(P<0.01).No significant adverse reactions were reported during treatment.Before treatment,there was no significant correlation between the SI of both groups and PVMD,PVV,SWV,LSM,HA,LN,PⅢNP,CⅣ,APRI,and FIB-4.In the observation group,FT showed a positive correlation with SWV,LSM,LN,PⅢNP,CⅣ,APRI,and FIB-4(P<0.05,P<0.01),while in the control group,FT showed a positive correlation with HA,LN,PⅢNP,CⅣ,APRI,and FIB-4(P<0.01).After treatment,in the control group,SI showed a positive correlation with APRI and FIB-4(P<0.05,P<0.01),but there was no significant correlation between SI in the observation group and FT in both groups with the above-mentioned indicators.Bioinformatics analysis identified four potential targets of Gandou Fumu Decoction for treating WD,namely heme oxygenase 1(HMOX1),peroxisome proliferator-activated receptor alpha(PPARα),small heat shock protein B1(HSPB1),and mitogen-activated protein kinase 3(MAPK3).Compared to the normal group,both the control and observation groups had significantly lower PPARαand HSPB1 expression and significantly higher HMOX1 and MAPK3 expression before treatment(P<0.01).Compared to before treatment within the same group,both groups showed significantly increased PPARα and HSPB1 expression and significantly decreased HMOX1 and MAPK3 expression after treatment(P<0.05,P<0.01).After treatment,the observation group had significantly higher PPARα and HSPB1 expression and lower HMOX1 and MAPK3 expression than the control group(P<0.05,P<0.01).Conclusion Gandou Fumu Decoction demonstrates remarkable advantages in improving clinical efficacy,Chinese medicine syndrome scores,iron metabolism,liver fibrosis progression,ultrasound imaging parameters,and ferroptosis-related biomarkers expression in patients with WD,with a favorable safety profile.
4.Visual analysis of the application of wearable devices in nursing care both domestically and internationally
Qing DONG ; Shujun XING ; Xianghuan LI ; Jing ZHAI ; Xinyu WANG ; Jiaqi LIU ; Jinlan LI ; Xiaoru GAO ; Yu TANG
China Modern Doctor 2025;63(30):1-4,68
Objective To analyze the research status,hotspots,and trends of wearable devices in nursing applications both domestically and internationally.Methods Using China National Knowledge Infrastructure,Wanfang Data Knowledge Service Platform,and Embase core databases as data sources,VOSviewer was used to visualize and analyze the publication time,keywords,and other relevant literature.Results Total of 428 articles were included,including 196 Chinese articles and 232 English articles.The overall publication volume showed an upward trend.Domestic research focuses on chronic diseases,artificial intelligence,and nursing,with the main research subjects being the elderly;Foreign research focuses on smart devices,self-monitoring,and quality of life,with the main research subjects being adults.Conclusion Currently,the number of publications on the application of wearable devices in nursing is relatively small,but the overall research heat is on the rise,mainly used for chronic diseases and self-monitoring.In the future,the application scope of wearable devices should be expanded and their potential value should be explored to promote the innovation and progress of nursing models.
5.Vasovagal syncope patients' experience of emotion management and program needs from the doctor-nurse-patient perspective: a phenomenological research
Yili GAO ; Haiping YU ; Baoxin TANG ; Yanfen DONG ; Ying XU ; Jiawen QIN ; Na LI ; Yongqing ZHANG
Chinese Journal of Modern Nursing 2025;31(4):462-469
Objective:To explore the experience of emotion management and program needs of patients with vasovagal syncope (VVS) from the doctor-nurse-patient perspective.Methods:This study was a phenomenological study in qualitative research. Using purposive sampling method, four medical specialists, four nursing specialists, and 10 patients with VVS from the Syncope Center of Shanghai East Hospital, Tongji University were selected from March to May 2024 for semi-structured interviews. Colaizzi's phenomenological data analysis was used to analyze the data.Results:Theme 1 was the initial perception and experience of emotion management, in which the doctor-nurse perspective included two sub-themes of emotion management met the actual needs of clinical patients and the management program was too specialized and unknown, and the patient perspective included three sub-themes of differences in the ability of individuals to recognize their own emotional state, lack of knowledge related to emotion management, and lack of social support. Theme 2 was the need for emotion management programs, in which the doctor-nurse perspective involved two sub-themes of multidisciplinary cooperation, suitable for clinical operation and follow-up, and the combination of online and offline, and in-hospital and out-of-hospital linkage, and the patient perspective involved two sub-themes of the need for healthcare guidance, easy to operate, and the diversification of forms, personalization, and meeting the needs of different populations.Conclusions:The content of emotion management is relatively unknown to doctors, nurses and patients, and even more so to patients. VVS emotion management work is still in its infancy, and emotion management as a branch of rehabilitation needs to be emphasized for its development, and psychological assessment and intervention work should be incorporated into the routine of syncope rehabilitation.
6.Association of hippocampal subfield volumes and cross-domain associative memory impairment in patients with schizophrenia
Zhao-lin ZHAI ; Di CHANG ; Xuan LI ; Chang LU ; Yu-ke DONG ; Yan WANG ; Chun-hong SHAO ; Qing KANG ; Deng-tang LIU
Fudan University Journal of Medical Sciences 2025;52(6):775-782
Objective To investigate the possible association between cross-domain associative memory(AM)impairment and hippocampal subfield volumes in patients with schizophrenia(SCZ).Methods We enrolled 28 SCZ patients from Shanghai Mental Health Center,Shanghai Jiao Tong University School of Medicine,and 28 healthy controls(HCs)between 2019 and 2021.Based on an innovative AM paradigm and automated segmentation,3D-T1 weighted data of the objects were processed with PhiPipe and FreeSurfer.Differences in subfield volums between the two groups were analyzed using ANCOVA,while their relationship with AM scores was assessed using Pearson correlation.Results SCZ patients exhibited significantly poorer AM performance across three conditions compared with HCs.Marginally significant reductions were observed in the total volume of bilateral hippocampus,encompassing both the hippocampal head and body.Significant volume reductions were identified in the bilateral presubiculum and parasubiculum.The volumes of bilateral presubiculum head(r=0.273,P=0.042),parasubiculum(r=0.397,P=0.002),and CA1 head(r=0.382,P=0.004)exhibited positive correlations with cross-domain AM performance.Conclusion The bilateral presubiculum and parasubiculum,as hippocampal subregions significantly associated with cross-modal AM deficits in SCZ,may play a crucial role in the pathology of AM.
7.Combined anterior and posterior miniscrews increase apical root resorption of maxillary incisors in protrusion and premolar extraction cases
Zhizun WANG ; Li MEI ; Zhenxing TANG ; Dong WU ; Yue ZHOU ; Ehab A. ABDULGHANI ; Yuan LI ; Wei ZHENG ; Yu LI
The Korean Journal of Orthodontics 2025;55(1):26-36
Objective:
Miniscrews are commonly utilized as temporary anchorage devices (TADs) in cases of maxillary protrusion and premolar extraction. This study aimed to investigate the effects and potential side effects of two conventional miniscrew configurations on the maxillary incisors.
Methods:
Eighty-two adult patients with maxillary dentoalveolar protrusion who had undergone bilateral first premolar extraction were retrospectively divided into three groups: non-TAD, two posterior miniscrews only (P-TADs), and two anterior and two posterior miniscrews combined (AP-TADs). Cone-beam computed tomography was used to evaluate the maxillary central incisors (U1).
Results:
The APTADs group had significantly greater U1 intrusion (1.99 ± 2.37 mm, n = 50) and less retroclination (1.70° ± 8.80°) compared to the P-TADs (–0.07 ± 1.65 mm and 9.45° ± 10.68°, n = 60) and non-TAD group (0.30 ± 1.61 mm and 1.91° ± 9.39°, n = 54).However, the AP-TADs group suffered from significantly greater apical root resorption (ARR) of U1 (2.69 ± 1.38 mm) than the P-TADs (1.63 ± 1.46 mm) and non-TAD group (0.89 ± 0.97 mm). Notably, the incidence of grade IV ARR was 16.6% in the AP-TADs group, significantly higher than the rates observed in the P-TADs (6.7%) and non-TAD (1.9%) groups. Multiple regression analysis revealed that after excluding tooth movement factors, the AP-TADs configuration resulted in an additional 0.5 mm of ARR compared with the P-TADs group.
Conclusions
In cases of maxillary protrusion and premolar extraction, the use of combined anterior and posterior miniscrews enhances incisor intrusion and minimizes torque loss of the maxillary incisors. However, this approach results in more severe ARR, likely due to the increased apical movement and composite force exerted.
8.Effect of Duhuo Jisheng Decoction on knee osteoarthritis model rabbits through regulation of cell pyroptosis mediated by PI3K/Akt/mTOR signaling pathway.
Lin-Qin HE ; Peng-Fei LI ; Xiao-Dong LI ; Qi-Peng CHEN ; Zong-Han TANG ; Yu-Xin SONG ; Han-Bing SONG
China Journal of Chinese Materia Medica 2025;50(1):187-197
This study aimed to investigate the underlying mechanisms of Duhuo Jisheng Decoction(DJD) in the prevention and treatment of knee osteoarthritis(KOA). Forty SPF New Zealand rabbits were randomly divided using SPSS 26.0 software into five groups: blank group, model group, low-dose DJD group, high-dose DJD group, and high-dose DJD+phosphatidylinositol 3-kinase(PI3K)/protein kinase B(Akt)/mammalian target of rapamycin(mTOR) signaling pathway activator group(high-dose DJD+740Y-P group), with eight rabbits in each group. Except for the blank group, the KOA model was established in the other groups using papain injection into the knee joint cavity combined with forced flexion of the knee joint. The day after modeling, the blank group and model group were given normal saline at 10 mL·kg~(-1) by gavage, the low-dose DJD group received DJD at 8.8 g·kg~(-1) by gavage, the high-dose DJD group received DJD at 35.2 g·kg~(-1) by gavage, and the high-dose DJD+740Y-P group received DJD at 35.2 g·kg~(-1) by gavage along with 740Y-P at 0.15 μmoL·kg~(-1) injected via the auricular vein. All groups received treatment continuously for four weeks. After modeling and intervention, behavioral observations were performed for all groups, and after the intervention, imaging assessments of the knee joints were conducted. Cartilage from the knee joints was collected, and gross morphological changes were observed. Pathological changes in cartilage tissue were examined using hematoxylin-eosin(HE) staining. The results of these observations were quantitatively evaluated using the Lequesne MG score, Kellgren-Lawrence(K-L) grading, Pelletier score, and Mankin score. ELISA was used to measure the levels of interleukin-1β(IL-1β), interleukin-18(IL-18), and matrix metalloproteinase 13(MMP13) in cartilage tissue. Real-time RT-PCR was used to detect the mRNA expression levels of PI3K, Akt, mTOR, Nod-like receptor protein 3(NLRP3), cysteine protease 1(caspase-1), and gasdermin D(GSDMD) in cartilage tissue. Western blot was employed to measure the protein expression levels of PI3K, Akt, mTOR, NLRP3, caspase-1, and GSDMD. The results showed that compared with the blank group, the model group exhibited significant knee joint degeneration, increased Lequesne MG score, K-L grading, Pelletier score, and Mankin score, elevated levels of IL-1β, IL-18, and MMP13 in cartilage tissue, activation of PI3K, Akt, and mTOR phosphorylation along with increased mRNA expression levels, and elevated protein and mRNA expression levels of NLRP3, caspase-1, and GSDMD. Compared with the model group, these indicators were reversed in both the low-dose and high-dose DJD groups, with the high-dose group showing greater decline degree than the low-dose DJD group. However, compared with the high-dose DJD group, the improvements in knee joint degeneration were less pronounced in the high-dose DJD+740Y-P group, with increased Lequesne MG score, K-L grading, Pelletier score, Mankin score, elevated levels of IL-1β, IL-18, and MMP13, activation of PI3K, Akt, and mTOR phosphorylation along with increased mRNA expression, and increased protein and mRNA expression levels of NLRP3, caspase-1, and GSDMD. In conclusion, DJD is effective and safe in the treatment of KOA, and its mechanism may be related to the inhibition of PI3K/Akt/mTOR signaling pathway-mediated pyroptosis in cartilage tissue, thereby improving knee joint bone structure, reducing the inflammatory response, and preventing cartilage matrix degradation.
Animals
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Drugs, Chinese Herbal/administration & dosage*
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Rabbits
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TOR Serine-Threonine Kinases/genetics*
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Osteoarthritis, Knee/genetics*
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Proto-Oncogene Proteins c-akt/genetics*
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Signal Transduction/drug effects*
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Male
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Disease Models, Animal
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Pyroptosis/drug effects*
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Phosphatidylinositol 3-Kinases/genetics*
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Humans
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Female
9.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
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Humans
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Consensus
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Drugs, Chinese Herbal/therapeutic use*
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Surveys and Questionnaires
10.Forty years of construction and innovative development of scientific regulation system of traditional Chinese medicine in China.
Jun-Ning ZHAO ; Zhi-Shu TANG ; Hua HUA ; Rong SHAO ; Jiang-Yong YU ; Chang-Ming YANG ; Shuang-Fei CAI ; Quan-Mei SUN ; Dong-Ying LI
China Journal of Chinese Materia Medica 2025;50(13):3489-3505
Since the promulgation of the first Drug Administration Law of the People's Republic of China 40 years ago in 1984, China has undergone four main stages in the traditional Chinese medicine(TCM) regulation: the initial establishment of TCM regulation rules(1984-1997), the formation of a modern TCM regulatory system(1998-2014), the reform of the review and approval system for new TCM drugs(2015-2018), and the construction of a scientific regulation system for TCM(2019-2024). Over the past five years, a series of milestone achievements of TCM regulation in China have been achieved in the six aspects, including its strategic objectives and the establishment of a science-based regulatory system, the reform of the review and approval system for new TCM drugs, the optimization and improvement of the TCM standard system and its formation mechanism, comprehensive enhancement of regulatory capabilities for TCM safety, international harmonization of TCM regulation and its role in promoting innovation. Looking ahead, centered on advancing TCMRS to establish a sound regulatory framework tailored to the unique characteristics of TCM, TCM regulation will evolve into new reform patterns, advancing and extending across eight critical fronts, including the legal framework and policy architecture, the review and approval system for new TCM drugs, the quality standard and management system of TCM, the comprehensive quality & safety regulation and traceability system, the research and transformation system for TCMRS, AI-driven innovations in TCM regulation, the coordination between high-quality industrial development and high-level regulation, and the leadership in international cooperation and regulatory harmonization. In this way, a unique path for the development of modern TCM regulation with Chinese characteristics will be pioneered.
Humans
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China
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Drugs, Chinese Herbal/standards*
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History, 20th Century
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History, 21st Century
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Medicine, Chinese Traditional/trends*

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